Sr. Director, Global Design Assurance
Company: Fox Rehabilitation
Posted on: January 15, 2022
Do you want to make a meaningful difference in the quality of
healthcare? Omnicell is empowering health systems and pharmacies to
radically transform the way they manage medications, so they can
achieve the vision of the Autonomous Pharmacy. Thousands of
hospitals, pharmacies, skilled nursing facilities and care homes
trust Omnicell to provide continuous innovation. They need us to
deliver solutions to meet the ever-evolving challenges of the
healthcare landscape. We encourage creative problem solving and
outside-the-box thinking that only a diverse, well-rounded
workforce can bring. Join us as we build on our powerful
combination of advanced automation, predictive intelligence, and
expert services to create a safer future for patients-one where
medication errors are a thing of the past. You'll be joining an
organization whose culture encourages individual development,
rewards intellectual curiosity, and embraces an inclusive
environment. Join our growing company and help shape the future at
Omnicell! Senior Director, Global Quality Design Assurance Are you
a Senior level quality design assurance leader who knows what it
means to Do The Right Thing? Seeking an AMAZING role in Design
Assurance? Omnicell has an exciting new role for you to join our
EXTRAORDINARY Quality Team. The Senior Director, Global Quality
Design Assurance will be responsible for leading a global team of
inspired quality professionals responsible for pre and post market
Quality Design Assurance and Product Regulatory activities. The
role focuses on developing and leading the quality strategies to
enable Omnicell product introductions and commercially released
product support. While working with key leadership on regulatory
strategies for enterprise and applications Cloud-based software
integrated with on-prem medical devices, one will develop and
maintain QMS processes to support SaMD and SaaS applications in
alignment with the advancing initiatives of the FDA's Digital
Health Center for Excellence. This Senior Director role provides
leadership for ensuring quality practices are integrated within and
across Omnicell's product development process. Through effective
communication, problem solving and collaboration across multiple
functions, this position will ensure the QMS processes are
structured to drive exceptional experience for Omnicell Customers.
Reporting to the Vice President of Global Quality and Product
Regulatory, this position will manage the Product Design Assurance
functions across Omnicell and be responsible for functional
budgeting planning, talent development and collaboration with the
senior leadership team to drive strategic plans.
- Supports the establishment and continual improvement of QMS
processes in direct support of Omnicell's design processes. -Plans,
directs and implements all Quality Design Assurance activities for
new and existing products including enterprise and applications
- Forms strong partnerships -with Engineering, Product, and
Manufacturing and provides effective support by devising long-term
strategies that improve quality.
- Leads the facilitation for the development of quality and
product regulatory specifications and processes for new
- Leads the Design Assurance team in the support of sanctioned
projects. Provide quality and compliance direction, facilitation,
coaching and mentoring for cross-functional personnel.
- Provides an active role in design reviews to assess quality,
compliance and business risk.
- Direct the Defect Management process for pre and post market
for all Omnicell products.
- Manage the team to ensure Design outputs meet Design inputs
including ensuring all products comply with the associate Product
- Manage and ensure all product regulatory requirements are met
for expansion into international markets as required to support
business growth, including all CE Markings, product certifications
are established and maintained.
- Development and delivery of executive level presentations
including the assessment of the effectiveness of the Omnicell
Product Development processes.
- FDA 510(k).
- Define cyber security requirements.
- Product registrations and establishments licensing. Required
Knowledge and Skills
- Proven record of accomplishment leading Global Design Assurance
- Demonstrable knowledge of Quality in a high technology
manufacturing and development environment (medical devices).
- Familiar with software quality processes and tools required for
high-quality software and systems release.
- Specific training and demonstrated success in applying quality
problem solving methods such as Software DFMEA, fishbone diagrams,
process capability analysis, 8D methodologies, CAPA, DoE, SPC,
- Excellent written, presentation and interpersonal skills. Basic
- Minimum 10+ years of experience in a Leadership Quality role,
ideally software design for medical products.
- Minimum 5+ years of experience in product design and
- Minimum 5+ years in managing technical teams.
- Experience leading change in a matrix organization and
integration of QMS.
- Proven record of accomplishment and experience in ISO 9001 or
ISO 13485 QMS environments.
- Strong experience in leadership, planning, and project
management. Preferred Qualifications
- Software medical device experience in post-market activities
- Travel - 20% domestic and international
- This role can be located in Pittsburgh, St. Petersburg,
Milpitas / Mt.View or Plano #LI-LS1 To protect our employees,
partners, and customers, Omnicell requires most U.S. employees to
either be fully vaccinated for COVID-19 or obtain approval from
Omnicell for an exemption and accommodationfora medical condition
or a sincerely-held religious belief or practice. Nothing in this
job description restricts management's right to assign or reassign
duties and responsibilities to this job at any time. All qualified
applicants will receive consideration for employment without regard
to race, sex, color, religion, sexual orientation, gender identity,
national origin, protected veteran status, or on the basis of
disability. Omnicell will not discharge or in any other manner
discriminate against employees or applicants because they have
inquired about, discussed, or disclosed their own pay or the pay of
another employee or applicant. However, employees who have access
to the compensation information of other employees or applicants as
a part of their essential job functions cannot disclose the pay of
other employees or applicants to individuals who do not otherwise
have access to compensation information, unless the disclosure is
(a) in response to a formal complaint or charge, (b) in furtherance
of an investigation, proceeding, hearing, or action, including an
investigation conducted by the employer, or (c) consistent with the
contractor's legal duty to furnish information.
Keywords: Fox Rehabilitation, Milpitas , Sr. Director, Global Design Assurance, Executive , Milpitas, California
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